Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients

Parkinson's Disease Clinical Trial

Official title:

Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02768896
• Other study ID #: 0182-16RMB
• Status: Not yet recruiting
• Phase: N/A
• First received: April 4, 2016
• Last updated: June 6, 2016
• Start date: June 2016
• Est. completion date: February 2018

Study information

• Verified date: June 2016
• Source: Rambam Health Care Campus
• Contact: Ilana Schlesinger, MD
• Phone: 972502062529
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device.

Description:

Patients with Parkinson's disease may have gait disturbances including freezing of gait. Visual and auditory stimuli may improve gait. Investigators will analyze brain wave during walking while giving the subject different stimuli.

The voltage fluctuation (in hundreds of microvolts) will be recorded using the EEG cap and amplifier into a computer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with Parkinson's disease that are ambulatory and can sign a written informed consent

Exclusion Criteria:

• Patients with Parkinson's disease who are not ambulatory

• Patients with dementia

• Patients that are blind

• Patients that have severe hearing impairment

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Baseline
Patients will walk naturally with EEG measuring brain waves
• visual stimuli
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
• Auditory stimuli
Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
• Visual and auditory stimuli
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Technion, Israel Institute of Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voltage fluctuation resulting from brain activity after visual stimuli	Change in brain wave activity after visual stimuli as compared with baseline measured in tens of micro-volts per second.	One hour	No
Primary	Voltage fluctuation resulting from brain activity after auditory stimuli	Change in brain wave activity after auditory stimuli as compared with baseline measured in tens of micro-volts per second.	One hour	No
Primary	Voltage fluctuation resulting from brain activity after visual and auditory stimuli	Change in brain wave activity after visual and auditory stimuli as compared with baseline measured in tens of micro-volts per second.	One hour	No